FDA UDI
In Commercial Distribution
🇺🇸 United States
MEICET
DI: 06975980570000
·
Model: MC88
·
Shanghai May Skin Information Technology Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MEICET
- Primary DI
- 06975980570000
- Version / Model
- MC88
- Company Name
- Shanghai May Skin Information Technology Co., Ltd.
- Labeler DUNS
- 544352306
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-01-30
- Public Version
- 1
- Public Version Date
- 2023-02-07
- Public Version Status
- New
- Public Device Record Key
- 534cca09-7e96-4f01-9c27-a4bc686e8988
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HCJ | Device, Skin Potential Measurement | Neurology | 882.1560 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47158 | Dermatoscopy system | A computer-based image storage and retrieval picture archiving and communication system (PACS) that together with a connected electronic dermatoscope, captures, stores, recalls, and supports dermatological analyses/diagnoses through preselected digital images supplemented with three-dimensional (3-D) information. It typically consists of an image acquisition electronic dermatoscope, base station, monitor, computer, printer, application software, and a trolley. It will facilitate image transmission to any part of the hospital or telemedicine without the need for physical copying/transport, and gives direct access to stored images for physicians, surgeons, referring physicians. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06975980570000 | GS1 |